The Path Forward:
Our Commitment to Action
To our ByHeart families,
We built ByHeart on a promise that every formula-feeding family deserves to feel confident in what they're feeding their baby. This outbreak compromised that promise, and we are determined to prevent this from happening again.
Since the start of the recall, we have cooperated closely with the FDA and worked alongside a team of independent experts to conduct an exhaustive investigation examining every ingredient we source, every process we run, and every surface in our facilities. We needed to understand how a pathogen that was previously not considered a likely hazard in infant formula¹ made its way into our product.
What we have learned has given us pivotal insights to inform our path forward. We have always been proud of our rigorous standards, and now we are making them even stronger, reflecting new knowledge in the science of safety. We are working with the FDA on the safe resumption of infant formula production, and these are the immediate steps we are taking.
Comprehensive Root Cause Investigation & Analysis
The FDA announced that it has concluded its inspection of ByHeart's facilities and has shared that it did not identify any deficiencies in ByHeart’s facilities that could explain the root cause of this outbreak.
The agency shared it will continue its investigation into ingredients, including the powdered milk ingredient produced by a third-party supplier where Clostridium botulinum was identified.
Our Actions: Testing & Verification
The seriousness of this outbreak demands the most innovative testing approach that will add industry-first C. botulinum protocols to a robust foundation of testing protocols that already exceeded industry standards.
Develop & Implement New C. botulinum Testing Protocols
We have worked with a reputable third-party lab partner to develop a new Clostridium botulinum-specific testing protocol with heightened sensitivity to previously used protocols that will be applied to every dairy ingredient and to finished batches before they are released from our facilities.
This is a standard without compromise - no dairy ingredient or final product leaves our facility until it is tested and confirmed negative for C. botulinum.
Third-Party Lab Testing
We have engaged IEH Laboratories as the independent third-party lab to run the multi-stage testing on every batch at every stage.
Regularly Review & Enhance Comprehensive Ingredient Testing
We will regularly review and enhance our comprehensive, multi-stage C. botulinum testing protocol, and continue to conduct and advance our safety protocols for B. cereus, Cronobacter, Salmonella, heavy metals and other contaminants.
QR-Enabled Product Traceability
We will launch a new traceability process to give parents a third-party verified view of the testing results for their specific batch of formula. This will include C. botulinum, B. cereus, Cronobacter, Salmonella, heavy metals, etc.
Our Actions: Manufacturing & Quality
We are implementing further enhancements to our manufacturing and quality control protocols to ensure the highest level of safety at every step.
Explore New Preventative Technologies & Manufacturing Steps
We are committed to continued innovation in our facilities and entire manufacturing process, exploring the latest technologies to enhance infant-grade safety. This includes new preventative technologies throughout our process, from sourcing to manufacturing.
Augment Facility Sanitation
In addition to the regular facility sanitation procedures, we will perform a full sporicidal sanitation on our infant formula facilities, followed by verification of its effectiveness, prior to resuming production.
Develop Enhanced Controls at Our Facilities
Between every production run, we will pause operations to complete a full, thorough cleaning and sanitization. Every product lot is carefully tested to ensure it meets our safety standards before reaching families. Our commitment is that whenever we return to production, we will regularly conduct independent on-site inspections to verify corrective actions and maintain the highest operating standards.
Maintain our Commitment to US Manufacturing
ByHeart is incredibly proud of manufacturing our products in the U.S. As we explore new supplier partnerships that will provide the highest quality dairy ingredients, we remain committed to domestic production.
Our Actions: Supplier & Ingredient Quality Assurance
We are working closely with our partners to ensure our high standards are met throughout our entire supply chain.
Build Increased Roster of Ingredient Suppliers
We are in the process of identifying new suppliers of certain ingredients that meet our infant formula standards to increase redundancy and ensure a safe and uninterrupted supply.
Expand Infant Formula-Grade Ingredient Specifications
We are adding specifications and criteria, based on what we’ve learned, to our comprehensive ingredient selection and annual evaluation process with suppliers.
This outbreak has proven that standard preventative and testing measures are no longer sufficient, and enhanced systems are needed to protect ingredients.
Increased Supplier-Level Dairy Ingredient Testing
We are increasing the frequency and scope of testing for all dairy ingredients to ensure they meet our stringent quality specifications.
Enhanced Supplier Audits
Expanding our supplier audit program to include more frequent and in-depth reviews of our partners' quality and safety processes.
Support New Safety Measures at Dairy Farms
We are engaging with suppliers and farm partners to review robust new control processes, with a particular focus on the critical processes of gathering and processing whole milk.
Our Actions: Food Safety Leadership & Training Culture
We are enhancing our internal training and creating a new external advisory council to validate our actions and stay ahead of future threats.
Safety Culture & Training
The Director of Learning & Development will expand our onboarding and training process. This role will lead the design and execution of learning programs that strengthen operational execution, food safety, and quality culture. This ensures training systems exceed regulatory requirements, embed food safety expectation and enable continuous improvement through effective learning.
Expert Advisory Council
We are establishing an independent Food Safety Advisory Council, composed of leading experts in food safety, microbiology, and public health. The council will provide strategic guidance on our food safety programs and proactive identification of emerging risks to help deliver the highest standards of quality and safety to families.
Food Safety Education
Support the development of food safety education from third-party experts and leaders to provide easy-to-understand, evidence-based information for parents.
Our Ongoing Commitment to You
We understand that rebuilding trust will take time and consistent, transparent action. We are committed to providing you with regular updates on our progress across all of these categories.
Sincerely,
The ByHeart Team
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